WO2010009390A2 - Traitement de revêtement biocompatible sur implants polymères - Google Patents

Traitement de revêtement biocompatible sur implants polymères Download PDF

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Publication number
WO2010009390A2
WO2010009390A2 PCT/US2009/050984 US2009050984W WO2010009390A2 WO 2010009390 A2 WO2010009390 A2 WO 2010009390A2 US 2009050984 W US2009050984 W US 2009050984W WO 2010009390 A2 WO2010009390 A2 WO 2010009390A2
Authority
WO
WIPO (PCT)
Prior art keywords
coating
calcium phosphate
substrate
polymeric material
thermal barrier
Prior art date
Application number
PCT/US2009/050984
Other languages
English (en)
Other versions
WO2010009390A3 (fr
Inventor
Afsaneh Rabiei
Original Assignee
North Carolina State University
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by North Carolina State University filed Critical North Carolina State University
Publication of WO2010009390A2 publication Critical patent/WO2010009390A2/fr
Publication of WO2010009390A3 publication Critical patent/WO2010009390A3/fr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K6/00Preparations for dentistry
    • A61K6/80Preparations for artificial teeth, for filling teeth or for capping teeth
    • A61K6/884Preparations for artificial teeth, for filling teeth or for capping teeth comprising natural or synthetic resins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials
    • A61L27/18Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28Materials for coating prostheses
    • A61L27/30Inorganic materials
    • A61L27/32Phosphorus-containing materials, e.g. apatite
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B15/00Layered products comprising a layer of metal
    • B32B15/04Layered products comprising a layer of metal comprising metal as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00Layered products comprising a layer of synthetic resin
    • B32B27/40Layered products comprising a layer of synthetic resin comprising polyurethanes
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00Layered products comprising a layer of synthetic resin
    • B32B27/42Layered products comprising a layer of synthetic resin comprising condensation resins of aldehydes, e.g. with phenols, ureas or melamines
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B9/00Layered products comprising a layer of a particular substance not covered by groups B32B11/00 - B32B29/00
    • B32B9/04Layered products comprising a layer of a particular substance not covered by groups B32B11/00 - B32B29/00 comprising such particular substance as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2420/00Materials or methods for coatings medical devices
    • A61L2420/02Methods for coating medical devices
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00Stock material or miscellaneous articles
    • Y10T428/26Web or sheet containing structurally defined element or component, the element or component having a specified physical dimension
    • Y10T428/263Coating layer not in excess of 5 mils thick or equivalent
    • Y10T428/264Up to 3 mils
    • Y10T428/2651 mil or less
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00Stock material or miscellaneous articles
    • Y10T428/31504Composite [nonstructural laminate]
    • Y10T428/31551Of polyamidoester [polyurethane, polyisocyanate, polycarbamate, etc.]
    • Y10T428/31609Particulate metal or metal compound-containing
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00Stock material or miscellaneous articles
    • Y10T428/31504Composite [nonstructural laminate]
    • Y10T428/31942Of aldehyde or ketone condensation product

Definitions

  • the present invention is directed to a method for preparing a biocompatible coated substrate.
  • the method comprises providing a substrate having a surface including a polymeric material, and applying a calcium phosphate coating to the substrate.
  • the coating is applied at a temperature below the melting point of the polymeric material.
  • the coating is applied using Ion Beam Assisted Deposition (IBAD).
  • IBAD Ion Beam Assisted Deposition
  • the coating can be applied at ambient conditions.
  • the calcium phosphate is selected from the group consisting of hydroxyapatite, tricalcium phosphate, and mixtures thereof.
  • Typical coating methods such as plasma spraying, are carried out at high temperatures, typically above the melting point of many polymeric materials that would be desirable as a medical device, such as an implant.
  • the present invention overcomes this problem by providing a method of coating a substrate formed of a polymeric material and coated substrates prepared according to the method.
  • Any polymeric material useful in forming a medical device may be used according to the present invention.
  • Non-limiting examples of polymeric materials that may be used according to the invention include acrylates, methacrylates, polyglycolic-polylactic acid copolymers, polyhydroxybutyrates, polyesters (such as
  • PEEK and polyurethanes are merely representative examples of polymeric materials that could be used according to the invention, and any polymeric material that may be used in a medical device that would benefit from being coated with an osteointegration enhancing material (e.g., calcium phosphate), or a ceramic material generally, could be used as a substrate according to the present invention.
  • an osteointegration enhancing material e.g., calcium phosphate
  • a ceramic material generally
  • the IBAD system comprises dual ion beam sputtering using a primary beam and an assist beam. It is understood, however, that the present invention is not limited to a single type of sputtering system, but could rather be practiced with any number of similar systems readily understood by one of skill in the art.
  • the primary ion source is an 8 cm Kaufman-type ion source, used for sputtering the source material from the target, and the secondary ion source is a 3 cm Kaufman-type source, used for ion bombardment.
  • At least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 95%, at least about 96%, at least about 97%, at least about 98%, or at least about 99% by weight of the calcium phosphate is amorphous.
  • Microwave heating is fast and well controlled to focus the heat at the calcium phosphate coating without damaging the polymeric substrate. Further, the technique has the advantage of preserving the integrity and strength of the polymer substrate.
  • the assisted beam of the IBAD system can enable the coating to form an atomically intermixed interface with the substrate that can further improve bonding strength compared to mechanical interlocking formed by plasma spraying. The application of such kinds of heat treatment enables heat treatment of the calcium phosphate coating in a very controlled and accurate manner.
  • heat treatment is via microwave or laser treatment
  • crystallization of the calcium phosphate is achieved.
  • the now crystallized calcium phosphate maintains its excellent bond strength resulting from the use of the IBAD system at room temperature to initially apply the coating.
  • Y sa is the surface of the yttrium strips; T sa is the total target surface area; Y sy is the yttrium sputter yield; and HA sy is the hydroxyapatite sputter yield. Further, Y sa can be determined according to the following equation:
  • the present invention allows for an even greater ability to engineer the coating on an atomic level to nanostructure the coating to predetermined specifications that maximize strength and durability in one phase of the coating while maximizing bioavailability (e.g., osseointegration) in another phase of the coating.
  • the present invention is particularly useful for forming calcium phosphate coatings on polymeric substrates, the coatings being functionally graded such that crystallinity of the coating varies across the thickness of the coating.
  • degree of crystallinity refers to the relative percentage of the calcium phosphate material present that is in a crystalline phase versus that present in a non-crystalline phase (e.g., an amorphous phase). A high degree of crystallinity would indicate the material present is predominately in a crystalline phase. A low degree of crystallinity would indicate the material present is predominately in a non-crystalline phase.
  • a coated substrate was prepared by depositing a hydroxyapatite film on a polyetheretherketone substrate in a dual ion beam sputtering system.
  • Six coated substrates were prepared.
  • Sample 1 was prepared by depositing a hydroxyapatite coating directly on the PEEK substrate using room temperature IBAD, while rotating the substrate.
  • Sample 2 was prepared by depositing a hydroxyapatite coating directly on the PEEK substrate using room temperature IBAD without rotating the substrate.
  • Sample 3 was prepared by depositing a titanium coating directly on the PEEK substrate using room temperature IBAD while rotating the substrate.
  • Sample 4 was prepared by depositing a titanium coating directly on the PEEK substrate using room temperature IBAD without rotating the substrate.

Abstract

L'invention concerne des substrats polymères comprenant un revêtement biocompatible, et des procédés de préparation de ceux-ci. En particulier, le revêtement peut être un matériau de céramique, en particulier un matériau de phosphate de calcium, qui peut être calibré fonctionnellement. L'invention fournit l'aptitude d'appliquer des revêtements haute qualité à des substrats polymères sans détériorer le substrat (par exemple par fusion du matériau polymère). Le matériau calibré fonctionnellement peut fournir du phosphate de calcium cristallin à proximité de l'interface de revêtement avec le substrat, et fournir du phosphate de calcium amorphe au niveau de la surface extérieure du revêtement.
PCT/US2009/050984 2008-07-18 2009-07-17 Traitement de revêtement biocompatible sur implants polymères WO2010009390A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US8200308P 2008-07-18 2008-07-18
US61/082,003 2008-07-18

Publications (2)

Publication Number Publication Date
WO2010009390A2 true WO2010009390A2 (fr) 2010-01-21
WO2010009390A3 WO2010009390A3 (fr) 2010-09-23

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2009/050984 WO2010009390A2 (fr) 2008-07-18 2009-07-17 Traitement de revêtement biocompatible sur implants polymères

Country Status (2)

Country Link
US (2) US8323722B2 (fr)
WO (1) WO2010009390A2 (fr)

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JP5518335B2 (ja) 2005-08-23 2014-06-11 スミス アンド ネフュー インコーポレーテッド 遠隔測定式の整形外科インプラント
WO2007103276A2 (fr) * 2006-03-03 2007-09-13 Smith & Nephew, Inc. Systemes et procedes d'administration d'un medicament
US20080206297A1 (en) 2007-02-28 2008-08-28 Roeder Ryan K Porous composite biomaterials and related methods
US11179243B2 (en) 2007-02-28 2021-11-23 Happe Spine Llc Implantable devices
US20090061385A1 (en) * 2007-09-05 2009-03-05 Bahcall James K Monolithic Dental Implant With Natural Load Response
US9144627B2 (en) 2007-09-14 2015-09-29 Exogenesis Corporation Methods for improving the bioactivity characteristics of a surface and objects with surfaces improved thereby
US20100227523A1 (en) * 2007-09-14 2010-09-09 Exogenesis Corporation Methods for improving the bioactivity characteristics of a surface and objects with surfaces improved thereby
JP5599806B2 (ja) 2008-10-15 2014-10-01 スミス アンド ネフュー インコーポレーテッド 複合材料創内固定器
JP5701783B2 (ja) * 2009-03-11 2015-04-15 エクソジェネシス コーポレーション 表面の生物活性特性を改善する方法とこの方法によって改善された表面をもつ物体
US8079737B2 (en) * 2009-04-20 2011-12-20 Harvatek Corporation Reflection-type light-emitting module with high heat-dissipating and high light-generating efficiency
CA2773162C (fr) * 2009-09-04 2016-11-29 The Procter & Gamble Company Appareil et procedes pour une demonstration visuelle de l'erosion dentaire sur des materiaux dentaires simules
US8673018B2 (en) * 2010-02-05 2014-03-18 AMx Tek LLC Methods of using water-soluble inorganic compounds for implants
EP2567012B1 (fr) * 2010-05-05 2015-12-16 Exogenesis Corporation Procédés d'amélioration des caractéristiques de bioactivité d'une surface et objets ayant des surfaces améliorées par ce procédé
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JP2014525817A (ja) 2011-08-22 2014-10-02 エクソジェネシス コーポレーション 物体表面の生物活性特徴の向上方法ならびにそれにより向上された表面
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TWI522231B (zh) 2014-12-01 2016-02-21 財團法人工業技術研究院 金屬/高分子複合材料及其製作方法
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CN106495723A (zh) * 2016-09-26 2017-03-15 陕西科技大学 一种适用于常压烧结法的碳纤维/碳化硅/羟基磷灰石人工骨复合材料的制备方法
US10588999B2 (en) * 2016-10-24 2020-03-17 N2 Biomedical Llc Mesoporous surface for enhanced bone integration
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WO2005067993A1 (fr) * 2004-01-19 2005-07-28 Stichting Katholieke Universiteit Procede de production d'implant polymere avec revetement de phosphate de calcium cristallin
US20060210494A1 (en) * 2005-03-16 2006-09-21 North Carolina State University Functionally graded biocompatible coating and coated implant

Also Published As

Publication number Publication date
US20100016985A1 (en) 2010-01-21
WO2010009390A3 (fr) 2010-09-23
US20130066425A1 (en) 2013-03-14
US8323722B2 (en) 2012-12-04

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